Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05096715

Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

Led by Massachusetts General Hospital · Updated on 2026-02-18

20

Participants Needed

3

Research Sites

492 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma. This study involves the following interventions: * Atezolizumab * Bevacizumab * Stereotactic body radiation therapy (SBRT)

CONDITIONS

Official Title

Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hepatocellular carcinoma (HCC) not suitable for surgery, transplant, or radiofrequency ablation
  • Up to 5 lesions with total tumor size less than 20 cm and no lesion over 15 cm
  • Diagnosis confirmed by biopsy or specific imaging criteria within 180 days
  • Measurable disease with at least one lesion of specified size
  • Small volume extrahepatic disease allowed if less than 2.0 cm in total diameter
  • Allowed prior transarterial chemoembolization (TACE) or drug eluting beads with 14-day washout
  • Age 18 years or older
  • ECOG performance status 0-1
  • Child-Pugh A liver function within 7 days
  • Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C)
  • No significant portal hypertension
  • Adequate organ and marrow function based on lab results within 7 days
  • Resolution of any significant prior treatment toxicity to Grade 1 or less except alopecia
  • No known HIV infection
  • Documented hepatitis B and C virus status with controlled viral load if infected
  • Women of childbearing potential must use contraception and have negative pregnancy test
  • Men with partners of childbearing potential must use contraception
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for liver cancer
  • Prior radiation to the liver region causing excessive normal tissue dose
  • Prior selective internal radiotherapy or hepatic arterial Yttrium therapy
  • Tumor extension into stomach, duodenum, small or large bowel
  • Extrahepatic metastases or malignant nodes larger than 2 cm
  • Known fibrolamellar, sarcomatoid, or biphenotypic HCC
  • History of leptomingeal disease
  • Gastrointestinal bleeding within 6 months
  • Major metastatic disease involving major airways or blood vessels
  • Active or history of autoimmune diseases with some exceptions
  • History of specific lung diseases or active pneumonitis
  • Active tuberculosis
  • Recent significant cardiovascular or vascular disease
  • Recent major surgery or trauma without recovery
  • History of other malignancies within 5 years except certain low-risk cancers
  • Severe infection within 4 weeks
  • Use of therapeutic antibiotics within 2 weeks
  • Prior organ or stem cell transplant
  • Significant bleeding or clotting disorders
  • Recent use of full-dose anticoagulants or thrombolytics
  • Recent minor surgical procedures before treatment
  • History of abdominal or gastrointestinal fistulas or perforations
  • History of intestinal obstruction or inflammatory processes within 6 months
  • Other diseases or conditions that increase risk or interfere with study
  • Uncontrolled illness or psychiatric/social issues limiting compliance
  • Recent live attenuated vaccine use or planned use during study
  • History of severe allergic reactions to similar drugs
  • Known hypersensitivity to study drug components
  • Untreated or high-risk varices without prior treatment
  • Moderate or severe ascites
  • Evidence of unexplained abdominal free air
  • Non-healing wounds, active ulcers, or untreated fractures
  • History of hepatic encephalopathy
  • Active co-infection of HBV and HCV
  • Known HIV infection
  • Untreated or progressing brain metastases
  • Recent use of high-dose aspirin or certain antiplatelet drugs
  • Chronic daily NSAID use except low-dose aspirin
  • Uncontrolled tumor-related pain
  • Uncontrolled fluid accumulations requiring frequent drainage
  • Uncontrolled or symptomatic high calcium levels
  • Prior investigational therapy within 28 days
  • Prior immunostimulatory or immunosuppressive treatments within defined periods
  • Uncontrolled hypertension or hypertensive crisis history
  • Other conditions contraindicating study participation or treatment safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

3

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

Loading map...

Research Team

J

Jennifer Y Wo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here